Summary

The purpose of this pre and post intervention observational study is to evaluate
patient-reported outcomes from an new clinical course which integrates Mindfulness and
Acceptance-based approaches from '3rd wave' Cognitive Behavioural Therapy with osteopathic
manual therapy treatment for patients with persistent pain.

It is being conducted by the British School of Osteopathy (BSO) in London. In Stage 1 (in
progress, June 2013 to August 2014), a course was developed for self-referring patients
attending the BSO Clinic. In Stage 2 (September 2014 to May 2016), delivery will be expanded
to evaluate outcomes for patients attending National Health Service (NHS) General
Practitioner (GP) surgeries in South East London.

The intervention consists of a pre-course screening interview; a structured course of six,
weekly, one-hour treatment sessions for individual patients; and an optional follow-up
interview after three months.

The evaluation study is being conducted by an independent study team from the National
Council for Osteopathic Research. Patients complete a set of standardised questionnaires
before the course and after six months to assess self-reported changes in quality of life,
well-being, activity levels, mindfulness and use of health resources. A sample of patients
will be invited to provide consent for a treatment session to be observed and/or recorded,
or to attend a follow-up interview after six months, to evaluate the quality of course
delivery. This is an observational study of patient-reported outcomes from a new
intervention in a single cohort of patients, so there is no formal study hypothesis but it
is anticipated that outcomes will include increased quality of life, well-being, and active
engagement with valued activities.

Study Design

This is a single group observational cohort study. Participants are adults with persistent musculoskeletal pain who choose to participate in an optional, six week pain self-management course which integrates mindfulness and acceptance-based exercises into osteopathic manual therapy treatment for individual patients.

pain self-management course

This is an observational study of patient-reported outcomes from an experiential pain self-management course which integrates mindfulness and acceptance-based exercises into osteopathic manual therapy treatment. The intervention consists of six, individual, one-hour osteopathic evaluation and treatment sessions which incorporate pain education, the development of mindfulness skills to enhance body awareness, and the identification of personal values to promote compassionate self-care and sustain commitment to active coping strategies. The intervention aims to enhance patients' well-being and resilience through developing psychological and behavioural flexibility in response to persistent pain.

Primary Outcomes

Measure

European Quality of Life Questionnaire (EQ5D)

time frame:
Pre-course baseline at week 0 to 30 weeks

Secondary Outcomes

Measure

Activity Avoidance Questionnaire (AAQ-IIR) Questionnaire

time frame:
Pre-course week 0 to week 30

Freiburg Mindfulness Inventory for mindfulness skills

time frame:
Pre-course week 0 to week 30

Bournemouth Questionnaire for pain-related beliefs and behaviour

time frame:
Pre-course week 0 to week 30

Self-reported changes in health resource utilisation

time frame:
Single measure at 30 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria:
- Adults over the age of 18
- Persistent musculoskeletal pain for more than six months duration
- Known medical diagnosis and stable condition
- Pain or pain-related behaviour limits activity
- Can identify scope for change
- Motivated to participate in a six week, experiential self-management course
- Suitable for osteopathic manual therapy
- Able to provide informed consent
- Sufficient spoken English to participate in consultations without an interpreter
- Able to attend the selected clinic locations when appointments are available
Exclusion Criteria:
- Do not conform to the inclusion criteria above
- Active, uncontrolled alcohol or substance abuse
- Active uncontrolled psychotic mental health problem
- Undergoing or awaiting further diagnostic medical investigations
- Currently attending a pain clinic or other psychological support service

Additional Information

Official title

Stage 2 Delivery and Evaluation of an Integrated Osteopathy, Mindfulness and Acceptance-based Programme for Patients With Persistent Pain

Principal investigator

Hilary Abbey, M.Sc.

Description

The OsteoMAP course is a new clinical intervention integrating Mindfulness and
Acceptance-based approaches of Cognitive Behavioural Therapy with manual therapy for
patients with persistent pain. In Stage 1 (in progress, June 2013 to April 2014) an
intervention for individual patients of six, structured, one hour sessions was piloted by
osteopaths at the British School of Osteopathy (BSO) in London with patients already
attending the osteopathic clinic. In Stage 2 (awaiting ethical approval, September 2014 to
May 2016) recruitment will be expanded to include NHS patients referred from, and treated
in, participating GP practices in South East London. The study aims to assess whether
participants report improved quality of life, well-being and engagement in personally-valued
activities six months after their course ends.
Osteopathy is a low risk form of manual therapy that promotes physical functioning in the
musculoskeletal system. Acceptance-based approaches promote a way of thinking that
encourages acceptance of unwanted experiences (i.e. symptoms which cannot be fully resolved)
by recognising that emotions, thoughts and physical sensations do not necessarily control
behaviour. Chronic pain is an increasing healthcare burden with significant psychological,
social and economic consequences but there is evidence that Mindfulness can be effective
with a range of mental and physical health problems, including chronic pain.
This observational evaluation study includes a 'before-and-after' patient-reported outcome
study with an embedded qualitative interview study and a fidelity evaluation. There is no
control group or comparison with standard care. The programme was funded as a new service
development, not primary research, but will generate new data from pre and post course
measures using standardised self-report questionnaires at baseline and after six months. The
fidelity assessment of adherence and competence will evaluate whether the course being
delivered as intended, independently observed by a team from the National Council for
Osteopathic Research (NCOR).
Recruitment: Posters will be placed in participating surgeries with information sheets for
doctors who wish to discuss the OsteoMAP course with patients. Patients will be invited to
'opt in' by completing application forms and invited to Pre-Course Interviews to screen for
eligibility and discuss the nature and potential benefits and risks of joining an
experiential course. Patients will complete standardised questionnaires before their
interview, either electronically on a laptop computer which submits data directly to the
evaluation team via Survey Monkey, or as paper copies with stamped addressed envelopes.
Pre-Course interviews aim to explore patients' willingness to try a new approach to pain
management and assess motivation and scope for change. Patients will be told about potential
psychological risks, as they will be invited to think about the full impact of pain and to
increase their awareness of both pleasant and painful experiences. Joint decisions will be
made about whether it is appropriate for a patient to join. If it is not clear, the patient
will be asked for permission to contact their doctor before a decision is made.
The Intervention: Patients will be invited to attend individual sessions, one hour a week
for six weeks, delivered by a clinical care team led by a qualified osteopath and up to
three senior student osteopaths. Sessions include osteopathic treatment, as appropriate for
each patient, and mindfulness and acceptance-based pain management exercises. Participants
will be asked to attend the full course, which is based on the structure outlined in a key
Acceptance and Commitment Therapy text by Russ Harris ('ACT Made Simple', 2009, New
Harbinger Publications).
Session 1: Living with pain - to help patients become more aware of how their current
reactions to discomfort limit them.
Session 2: Living more flexibly with pain - to promote acceptance and create opportunities
for choosing more flexible, active responses.
Session 3: Living in the present - to strengthen mindfulness skills, body awareness and
develop skills to integrate painful and pleasant experiences into present moment awareness
and action.
Session 4: Living a fulfilling life - to help patients become more aware of their values and
goals, build self-compassion, and engage with personally valued activities.
Session 5: Overcoming obstacles - to help patients develop the skills to overcome unworkable
habitual reactions to pain, and maintain engagement with values-based activities.
Session 6: Moving on - to help patients create personal self-care plans to promote
well-being and resilience and sustain their choices to do the things that matter.
At the end of each session, patients will be invited to choose home practices to develop
self-care skills and explore activities they may avoid because of pain. Activities are
optional and patients can choose to withdraw at any time, without giving a reason and with
no effect on their existing or future healthcare.
Follow-up: Patients will be offered optional follow-up interviews (not including treatment)
three months after their course ends.
The following ethical concerns have been addressed:
Confidentiality: This study does not involve access to NHS patients' medical records. Paper
copies of personal and medical information (e.g. application forms, osteopathic case
records) will be stored securely by the OsteoMAP care team in administrative offices, in
line with current guidelines and standard BSO operating policies. Paper copies of consent
forms and anonymised audit data will be stored securely in locked cabinets and on password
protected computers in BSO staff offices. Only the care team will have access to clinical
intervention data, and only the evaluation team will have access to questionnaire data.
Patient outcomes will be collected as online questionnaires via Survey Monkey. A laptop
computer will be provided by the clinical team at the patient's first appointment to
facilitate questionnaire completion. Participants will submit their own data directly,
immediately downloaded to the evaluation team, so no personal details or data will be
retained on the computer. Participants who wish to complete paper questionnaires will be
asked to post them directly to the evaluation team in the stamped, addressed envelopes
provided. After six months, follow-up questionnaires will be distributed directly to
participants by the evaluation team, by email or post (as requested by the patient). Study
data will be anonymised and patients will be allocated unique identifying numbers. The
database will be stored by the evaluation team on a secure bespoke research server at Queen
Mary University, London.
Courses will be run in private treatment rooms at the BSO and in GP surgeries in which rooms
have been made available for OsteoMAP clinicians. Personal or identifying details will be
deleted from interview transcripts, verbatim quotes used to illustrate findings will be
anonymised, and any potentially identifying details will be altered or deleted from all
written reports.
Coercion to join the course: This has been minimised by adopting an 'opt-in' policy.
Practitioners can discuss potential benefits and risks but cannot directly refer patients
onto the course. Participants will be fully informed about the nature of the course and it
will be emphasised that it is a voluntary self-management option being provided by the BSO,
an organisation outside the NHS, and that choosing to participate, or not, will not affect
their usual healthcare. They will be asked to 'opt-in' on a Patient Application Form.
Coercion to participate in course activities: This has been minimised by ensuring that
participants are aware that activities are optional and each session is guided by their
personal goals and needs. Participants will be made aware that they can choose to withdraw
from a session, or the whole course, at any time, without giving a reason, with no detriment
to their usual care.
Risk of physical harm: Mindfulness interventions and osteopathic care are both considered as
low risk interventions. Risks have been minimised through the use of inclusion and exclusion
criteria and screening interviews to check that participants are considered suitable. The
risks associated with manual therapy are low at <1: 50,000 - 100,000 of a serious adverse
event after manipulation. The risks are even lower with other conservative (i.e. massage)
techniques used by osteopaths. Around half of patients may feel some short-lived (<24 hours)
of minor muscle soreness after their first treatment. The practitioners responsible for
delivering the courses are clinically and educationally experienced and have received
additional OsteoMAP training. The student osteopaths involved are in their final year of
training, have been assessed as clinically competent, and will be carefully supervised in
each session.
Risk of psychological harm: Chronic pain is often associated with co-morbid mental health
issues such as anxiety and depression, and the risk of causing harm to vulnerable patients
has been minimised though the use of standardised questionnaire measures, inclusion and
exclusion criteria, and screening interviews to check that participants are able and willing
to participate in Mindfulness-informed interventions, which are also considered low risk.
This experiential course involves participants thinking about experiences of pain and the
effects on their life, an approach which has an inherent potential to cause some emotional
distress, which is clearly explained in the Information Sheets and Pre-Course interviews. In
treatment sessions, participants will be invited to try experiential activities and informed
in advance that these may cause some distress, a normal part of the process of exploring and
confronting beliefs and behaviour related to chronic pain. A qualified osteopath will be
available for any participants who need extra support during a session and the Project
Leader and Programme Developer will be contacted in the event of an adverse event.
Supervision for clinicians will be provided by the Programme Developer, an experienced
Chartered Clinical and Health Psychologist and Mindfulness teacher.
Quality assurance: The OsteoMAP Project Board report to the BSO Academic Council and are
subject to standard operating and quality assurance procedures. The clinical course is
supported by Patient Workbooks and Practitioner Training Manuals and is being externally
observed and internally audited. Practitioners delivering the course have participated in
additional training, and the quality of training and adherence and competence to the study
protocol is being monitored by the evaluation team.
Project oversight: The Chief Investigator/Project Leader, Programme Developer and
Administrator prepare activity and budget reports for the Board, which meets at least three
times per year, and annual reports for the Department of Health. Local audits will be
prepared annually as information for doctors about patient activity in their surgeries.